Intended Use | A biomaterial used for the repair and replacement of human tissue, manufactured by processing human bone powder mixed with additives. |
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Instructions for Use |
Preparation Before Use1) Before using the product, the physician examines the patient’s tissue defect and selects the appropriate product.2) Determine the product's quantity based on the size of the treatment site and the procedure method. 3) Check the packaging condition and ensure there is no damage to the product. 4) Open the packaging and take out the product. 5) Verify the sterilized packaging condition before use. Usage and Operation Instructions1) Aseptic technique must be maintained to minimize the risk of postoperative complications. The required amount of product is determined based on the type of procedure and the size of the defect to be treated.This product does not require rehydration before use. 2) The product packaging is designed to facilitate use in the surgical area. ① Remove the outer packaging (box) and open it.② Peel off the inner packaging (blister) to access the product and transfer it to the sterile field. ③ For bottle-type containers, extract the desired volume and use as needed. ④ For syringe-type containers, remove the protective cap at the tip just before use and press the plunger to dispense the desired amount ⑤ For 1cc syringe-type containers, attach the provided accessory (syringe adapter) to the tip of the container. This narrows the opening, allowing the contents to be dispensed slowly and in small amounts. Post-Use Storage and Handling Instructions1) The product is intended for single use only and must not be reused.2) Dispose of opened packaging as medical waste in accordance with waste management regulations. Storage Method and Shelf LifeShelf life: 2 years.Storage condition: Store at room temperature |
Precautions for Use |
General Precautions1) Do not reuse; the product is intended for single use only.2) Ensure the sterilized packaging is intact before use. 3) Do not use products with damaged or opened packaging. 4) Do not use products that have exceeded their expiration date. 5) Handle the product carefully to avoid contamination. Dispose of or return any contaminated product. 6) Do not re-sterilize previously sterilized products. 7) The product must be used by qualified healthcare professionals and should not be used for purposes other than its intended use. 8) Do not use the product on sites with bacterial infections, around infected areas, or where infection is progressing unless prescribed by the attending physician. |